Idem Translations will attend the 10x Medical Device Conference May 12-14, 2014 in Minneapolis, MN.

Idem Translations will be attending the 2014 Medical Device 10X Conference – An event focused on growth strategies for Medical Device companies. Topics will include:

• What European Reg Changes Mean For Your Business
• Leading Causes of Success or Failure in a Medical Device Start Up
• A Regulatory Primer for MedDev Manufacturing and Operations
• Development Considerations Taken By Successful MedDev Startups
• Extractables and Leachables Testing for Medical Devices

Idem Translations will attend the DIA Global Labeling 2014 Conference in Bethesda, MD April 9-10th.

Idem Translations will be attending the 2014 Global Labeling Conference April 9-10th where regulators and industry representatives will discuss the impact of recent global labeling guidelines and regulations including:

• EU global pharmacovigilance guidelines
• Draft and new FDA guidances
• Plain language initiative in Canada
• Risk management regulations in Japan
• Other emerging labeling guidances (Canada, European Union, Japan, US)

For more information, click on the image below.

DIA2014

Idem Translations attended the ASCPT Conference March 18-22, 2014 in Atlanta, GA

Idem participated in the annual conference for the American Society for Clinical Pharmacology and Therapeutics March 18-22, 2014. The event was held in Atlanta, GA. Over 1,100 scientists, clinicians and educators attended this meeting in 2014 to learn, connect, and network. This meeting is the preferred clinical pharmacology and therapeutics conference.

ASCPT 2014

Idem receives recognition for NCC ACRP Sponsorship

Idem receives recognition from The Northern California Chapter of the Association of Clinical Research Professionals (NCC ACRP) for the sponsorship of the education event, Medical Device Trails – What We Need to Know about Audits and Inspections.  The event was a great success with over 85 attendees who gathered a lot of information from the speaker Karen Bielinski from CARA-Consulting LLC.  “These events are a valuable service to the clinical trial professionals and the communities we serve. Without Idem as a sponsor, we would not be able to provide this service.” – Kathryn Howard, NCC ACRP

Pictured below – Mariam Nayiny, Idem President; Bonnie Miller, NCC ACRP President; Marygrace Barasi, Idem Sr. Project Manager

Idem selected as a key translation provider for Quorum Review

Idem Translations, a leading provider of translation services to the Life Sciences industry, announced their selection as a key translation partner for Quorum Review IRB.

This partnership is not only an honor but also a significant benefit for Idem clients who use Quorum Review’s services. As an approved vendor, Quorum accepts translations certified by Idem without any further cost or review.

Idem is proud to now be counted among this elite list of accepted vendors. It is a testament to the consistent quality of their work and the superb service provided. More importantly, Idem recognizes the great value that this has for clients!

About Quorum Review

Quorum Review is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been providing ethics review of drug and device trials since 1992. Quorum oversees research in accordance with U.S. and Canadian human research subject protection regulations, guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.

Quorum’s best-in-class service and support includes 3 protocol board meetings a week, daily amendment board meetings, 24 hour site review, 36 hour amendment review, and a secure OnQ™ web portal for online submissions, downloads and submission status review. Quorum can review studies in the US and Canada, review federally funded studies and has a specially designated Phase I study management team.

For information about Quorum Review services: www.quorumreview.com

Idem to participate in the 2013 LocWorld Life Sciences Roundtable

Idem Translations will participate in the 2013 Life Sciences Roundtable taking place at the LocWorld conference taking place in Silicon Valley on Oct 8th and 9th. In the world of translation, the life sciences sector is different from any other industry because of the unique nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. The  Life Sciences Business Round Table offers a program focused specifically on the challenges of life sciences localization. Subject matter professionals, clients and vendors will be presenting and sharing their thoughts and experiences on specific processes as well as the variety of requirements and challenges at work in the life sciences industry today.

LS Roundtable Logo Capture

Idem Translations Sponsors the RAPS 2013 Conference

Idem Translations is proud to sponsor the RAPS – 2013 Regulatory Convergence taking place in Boston, MA from Sept 28 to Oct 2. This event gathers regulatory professionals who work in medical device, pharmaceutical, and biotechnology sections. In addition to working with submission and compliance, these regulatory professionals play integral roles in all stages of the health care product lifecycle from development to marketing and post-market surveillance.  This event’s intensive workshops, educational sessions and networking events come together in a program designed by regulatory experts who understand the challenges and opportunities faced by today’s regulatory professionals.  We look forward to seeing you at our booth – number 2005.

Idem Translations Achieves EN15038:2006 Certification

Firm follows the best practices model designed exclusively for the translation industry

Palo Alto, California, January 29, 2013 – Idem Translations, Inc., a full-service provider of translation and localization services, has achieved EN 15038:2006 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and ISO 13485:2003 international standards.

This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.

EN 15038:2006 was developed by the European Committee for Standards (CEN) to establish and define the requirements for the provision of quality services by translation service providers. The standard encompasses the core translation process, including commissioning, translation, proofreading, review, project management, quality control, traceability, and delivery. It helps describe and define the entire service and offers a set of best practices for all aspects of the translation and localization process.

Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.

“The best practices outlined in EN 15038 set the industry standard for the highest quality language services,” said Mariam Nayiny, president of Idem Translations, Inc. “Idem’s certification to this standard confirms that our audited procedures are designed to consistently produce the quality results expected by our life sciences clientele.”

“Achieving EN 15038 certification demonstrates that a translation service provider has successfully implemented the processes considered necessary to ensure quality translation, including traceability of linguistic resources and the specialized professional competencies required of translators,” said Charles Clark, technical product development manager, Management Services of TÜV SÜD America Inc.

t-en15038

Idem Translations Achieves ISO 13485:2003 Certification

Firm holds specific quality certification for the translation of Life Sciences materials

Palo Alto, California, January 24, 2013 – Idem Translations, Inc., a full-service provider of translation and localization services, has achieved ISO 13485:2003 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and EN15038:2006 international standards.

This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.

ISO 13485:2003 is a globally recognized standard developed by the International Organization for Standardization (ISO) that specifies the requirements for quality management systems (QMS) in the medical device industry. In order to be certified to the ISO 13485:2003 standard, companies must demonstrate the implementation, maintenance, and effectiveness of a medical device QMS that identifies, manages, and minimizes risks associated with the manufacturing of medical devices and related services.

Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.

“ISO 13485:2003 distinguishes Idem from other language service providers because it demonstrates our understanding of the regulatory environment in which our clients operate,” said Mariam Nayiny, president of Idem Translations, Inc. “By meeting the same rigorous requirements to which our medical device clientele adhere, we are uniquely able to manage risk and maintain effective processes for their benefit.”

“Achieving ISO 13485:2003 certification exhibits Idem’s commitment to quality,” said Craig Casillas, vice president, Management Services, TÜV SÜD America Inc. “It demonstrates companywide dedication and teamwork to continually monitor quality and consistently follow well-organized processes.”

t-iso13485

Idem Announces Winner of ACRP 2010 Global Conference and Exhibition Raffle

As a sponsor of the ACRP 2010 Global Conference and Exhibition Idem raffled a full conference pass valued at $1,199 dollars for the event which took take place April 23-27th in Tampa.  We are proud to announce that the pass was awarded to Chris Cain, VP of Clinical Affairs from PAVAD Medical. Congratulations Chris!

One of the main learning objectives of this year’s conference was to identify the implications for global clinical research, such as recruitment efforts within special populations, consenting vulnerable populations and regional regulatory and legal issues. As a leader in certified translations for the Life Science community, Idem feels it is important to support this critical industry event. We enjoyed attending the event and interacting with industry leaders.

Pictured below: Nancy Kellen next to the recognition of bronze sponsors at entrace of exhibit hall.

About Association of Clinical Research Professionals
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 30 years later, ACRP is a global association comprised of more than 20,000 individuals in over 60 countries dedicated to clinical research and development. Our mission: To provide global leadership to promote integrity and excellence for the clinical research profession.
For more information visit: www.acrpnet.org.